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FDA Grants Priority Review for GSK’s Arexvy to Expand RSV Vaccine Age Range to 50-59
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The U.S. Food and Drug Administration (FDA) has initiated a priority review of GlaxoSmithKline’s (GSK; NYSE: GSK) application to extend the age range for its respiratory syncytial virus (RSV) vaccine, Arexvy, to include individuals aged 50 to 59 who are at increased risk for RSV disease. Arexvy was previously approved…
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CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for two of its drug candidates: CMS-D001 and CMS-D002. CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor aimed at treating immune inflammatory diseases, including…
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Sinovent Enrolls First Patient in Phase III Trial for Gout Drug XNW3009
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Suzhou-based Sinovent Inc. has announced the enrollment of its first patient in a Phase III clinical study for XNW3009, a novel gout drug candidate designed to inhibit the human urate transporter 1 (URAT1) and address gout-related hyperuricemia. Founded in 2016, Sinovent operates across multiple locations, including Beijing, Shanghai, Australia, and…
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ChinaGene Secures CDE Approval for ZVS101e Gene Therapy Targeting Retinitis Pigmentosa
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Beijing-based ChinaGene Technology Co., Ltd. has announced that it has received tacit clinical approval from the Center for Drug Evaluation (CDE) for its ophthalmic gene therapy ZVS101e, designed to treat retinitis pigmentosa (RP) patients with the RHO-R135W (RHO c.403C>T) mutation. This follows a tacit trial approval granted in the United…
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Yantai Dongcheng Acquires Full Rights to Alfatide II, Targeting Diagnostic and Therapeutic Applications
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Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) has announced its acquisition of all rights to alfatide II across all diagnostic and therapeutic fields and indications. Alfatide II, initially developed by Dr. Chen Xiaoyuan and previously licensed to Jiangsu Xinrui Pharmaceutical Co., Ltd. for further development, is currently in the…
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Nanjing Zenshine’s ZX-7101A NDA Accepted by NMPA for Uncomplicated Influenza Treatment
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Nanjing Zenshine Pharmaceuticals Co., Ltd., a China-based small molecule drug developer, has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ZX-7101A, an anti-influenza treatment targeting uncomplicated influenza in adults. The NDA is supported by data from a multi-center, randomized, double-blinded, placebo-controlled Phase…
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Gilead’s 2023 Flat Sales Reflect Stagnation and COVID-19 Demand Decline
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Gilead Sciences Inc. (NASDAQ: GILD) has reported a stagnant performance for the year 2023, with total product sales remaining unchanged at USD 26.9 billion. Amid a broad decline in demand for COVID-19 treatments, the company’s antiviral Veklury (remdesivir) sales could not offset the downturn, although HIV sales increased by 6%…
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Astellas Pharma Inc. Reports 2.1% YOY Growth in Q1-Q3 Fiscal 2023 Revenues
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Tokyo-based pharmaceutical company Astellas Pharma Inc., (TYO: 4503) has announced financial results for the first three quarters of its fiscal year 2023, ending December 31, 2023. The corporation reported a year-on-year (YOY) increase of 2.1% in global revenues, reaching JPY 1,189 billion (USD 8 billion) over the nine-month period. Astellas’…
